Eisai Begins 2 Phase 3 Trials to Further Assess FYCOMPA
Eisai announced the beginning of 2 multi-center, global phase 3 clinical trials assessing FYCOMPA (perampanel).
Eisai announced the beginning of 2 multi-center, global phase 3 clinical trials assessing FYCOMPA (perampanel). FYCOMPA is indicated as an adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures and primary generalized tonic-clonic seizures in patients with epilepsy who are 12 years or older.
One study includes a participant group consisting of patients 2 years and older with inadequately controlled seizures associated with Lennox-Gastaut Syndrome (LGS) (Study 338), while the other includes individuals aged 4 to 11 years who have inadequately controlled POS (Study 311).
Study 311 will be the first to follow the 2015 FDA communication to sponsors that allows companies to "to extrapolate to pediatric patients 4 years of age and older the effectiveness of drugs approved for the treatment of POS in adults." In the end, results from Study 311 will provide data on the long-term, open-label safety data for the drug as it pertains to patients 4 years and older.
The goal of Study 338 is to determine whether FYCOMPA is superior to a placebo when used as an adjunctive antiepileptic treatment, specifically in patients at least 2 years of age with LGS and inadequately controlled seizures. The trial may also provide insight into whether FYCOMPA can reduce the incidence of all seizures when utilized as an adjunctive antiepileptic treatment.
"We are committed to helping the epilepsy community through the continued development of options that may address unmet medical needs," said Lynn Kramer, MD, chief clinical officer and chief medical officer of the Neurology Business Group at Eisai, in a press release. "Through the initiation of these 2 clinical trials—one that looks at the pediatric population and the other involving those with LGS—we hope to demonstrate the value of perampanel for a broader range of patients who suffer from these conditions."
The most common adverse effects of FYCOMPA are dizziness, somnolence, fatigue, irritability, falls, nausea, weight gain, vertigo, ataxia, headache, vomiting, contusion, abdominal pain, and anxiety.